Cleared Traditional

K953964 - LUMISYS, LUMISCAN 20

K953964 is an FDA 510(k) clearance for LUMISYS, manufactured by Lumisys, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K953964 · Lumisys, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
27d
Days
Class 2
Risk

K953964 is an FDA 510(k) clearance for the LUMISYS, LUMISCAN 20. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Lumisys, Inc. (San Leandro, US). The FDA issued a Cleared decision on September 18, 1995 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K953964

510(k) Number K953964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date September 18, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LMA Digitizer, Image, Radiological

All 59
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K953964.
ASPECT ACQUISITION MODULE (AAM)
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DFS-2100
K932760 · Dba Systems, Inc. · Oct 1994
AD/V A.5
K925799 · Adaptive Video, Inc. · Feb 1994
K953964 · LUMISYS, LUMISCAN 20
Download PDF FDA Summary Lumisys, Inc.